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Clinical trial

A Double-blind, Randomized, Two-period, Two-treatment, Two-sequence, Crossover, Balanced, Single Subcutaneous Dose Pharmacodynamic Comparative Equivalence Study of Enoxaparin Sodium Pre-filled Syringes BP (Injection) 40 mg/0.4 ml (4,000 IU/0.4 mL) of Venus Remedies Limited, India and 'Clexane®' (Enoxaparin Sodium Injection Solution in a Pre-filled Syringe) 4,000 IU (40 mg)/0.4 ml of Sanofi, Germany in Healthy Adult Human Subjects Under Fasting Conditions

NCT05265676 is registered in ClinicalTrials.gov with Venus Remedies Limited as lead sponsor.

NCT NCT05265676
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Registry record

As filed in ClinicalTrials.gov.

Title
A Double-blind, Randomized, Two-period, Two-treatment, Two-sequence, Crossover, Balanced, Single Subcutaneous Dose Pharmacodynamic Comparative Equivalence Study of Enoxaparin Sodium Pre-filled Syringes BP (Injection) 40 mg/0.4 ml (4,000 IU/0.4 mL) of Venus Remedies Limited, India and 'Clexane®' (Enoxaparin Sodium Injection Solution in a Pre-filled Syringe) 4,000 IU (40 mg)/0.4 ml of Sanofi, Germany in Healthy Adult Human Subjects Under Fasting Conditions
Lead sponsor
Venus Remedies Limited
Phase
Phase 1
Overall status
Completed
Start date
February 26, 2021
Completion date
March 11, 2021
Enrollment
24 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

healthy